Genmab and GlaxoSmithKline (GSK) have announced the submission of a new drug application (NDA) for Arzerra (ofatumumab) to the Japanese Ministry of Health, Labor and Welfare (MHLW). Arzerra (ofatumumab) is submitted for the approval ...
Tags: new drug application, Arzerra, chronic lymphocytic leukemia
AstraZeneca and Ardea Biosciences have entered into a definitive merger agreement, under which AstraZeneca will acquire Ardea for $1.26bn including a product lesinurad in Phase III development for gout. As per the agreement, AstraZeneca ...
Tags: AstraZeneca, Ardea, merger agreement, gout
Watson Pharmaceuticals has confirmed favorable US District Court for the District of Delaware ruling in generic Sanctura XR (trospium chloride extended-release capsules) patent suit. The Court has ruled that the asserted claims of US ...
Tags: treatment of overactive bladder, pharmaceutical product
Raptor Pharmaceutical has submitted a new drug application (NDA) to the FDA for marketing approval of Cysteamine Bitartrate delayed-release capsules (RP103), to treat nephropathic cystinosis. Raptor has appealed for priority review of ...
Tags: clinical trial, pharmaceutical product, new drug application
Horizon Pharma has filed a patent infringement lawsuit in the US District Court for the District of Delaware against Par Pharmaceutical. The suit is related to an abbreviated new drug application that Par filed with the FDA to market ...
Tags: Patent, Lawsuit, drug application